Electrohysterogram-based sensor for non-invasive contraction monitoring with impr

基于宫腔电图的传感器，用于通过 impr 进行无创宫缩监测

• 批准号: 8001661
• 负责人: Neil R. Euliano
• 金额: $ 39.15万
• 依托单位: CONVERGENT ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-15 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001661
• 关键词: Acoustics; Adhesives; Attention; Back; Catheters; Cervical; Clinical Research; Computer software; Data; Development; Diagnostic; Discipline of obstetrics; Documentation; Electrodes; Electronics; Ensure; Evaluation; Fetal Heart; Fetal Heart Rate; Frequencies; Goals; Good Clinical Practice; Individual; Infection; Marketing; Membrane; Methods; Monitor; Movement; Nature; Nurses; Nursing Staff; Obesity; Obstetric Delivery; Patients; Phase; Population; Positioning Attribute; Preparation; Production; Publications; Quality Control; Research; Risk; Rupture; Signal Transduction; System; Technology; Testing; Time; Ultrasonography; Uterine Contraction; Uterine Monitoring; Uterus; Validation; Woman; Work; base; design; experience; fetal; improved; next generation; non-invasive monitor; novel; nursing intervention; pandemic disease; pressure; prototype; public health relevance; sensor; software development; standard of care; transmission process

DESCRIPTION (provided by applicant): The majority of obstetric deliveries in the US undergo continuous electronic uterine activity monitoring. Typically, an external tocodynamometer (strain gauge) is employed to provide the frequency and timing of uterine contractions. In some patients, particularly the obese, the monitor fails to detect contractions consistently. In others the monitor requires frequent repositioning by the nursing staff. The only available alternative is an invasive intrauterine pressure catheter (IUPC), with its associated increased risk of infection. The obstetric suite is subject to the obesity pandemic in the US, and these women have an increased risk for labor problems, infections and other complications. The specific goal of the proposed research is to develop a reliable, non-invasive uterine activity monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer. The end-product will be a "Smart EHG Cable", called the eToco that converts the electrical activity of the uterus (electrohysterogram or EHG) into uterine activity signals compatible with existing monitors. The eToco system will plug into the toco or IUP port of existing monitors and provide more robust and reliable contraction curves with less nursing intervention required and improved patient comfort. Phase I results indicate that the EHG can provide such a monitor with a simple four electrode array. The electrode array will be a single mesh with an adhesive backing for ease of placement. This project proposes the following specific aims: Aim 1: Build production-equivalent prototype toco-replacement EHG hardware, software, and electrode mesh - An electrode mesh/array will be designed and prototyped based on the optimal positioning found in Phase I. In addition, production-equivalent hardware and embedded software for the eToco system will be designed and built. To support FDA clearance, a quality system will be initiated during product design. Aim 2: Clinically evaluate the mesh EHG uterine activity monitor -All data will be collected to the standards of the FDA Good Clinical Practice (GCP) and will be sufficient to provide statistical significance. The clinical study is in two parts: the first will evaluate the system in 130 patients versus the toco and IUP and the second part will evaluate the interpretation of skilled clinicians on the three signals to ensure similarity. Aim 3: Preparation for submission of FDA 510(k) for toco-replacement system - all necessary quality control systems will be implemented during this project. In addition, the 510(k) submission will be prepared. Aim 4: Initial testing of an acoustic sensor for fetal heart rate monitoring - The next generation product will include a more reliable replacement for the ultrasound FHR sensor. A prototype acoustic sensor will be tested as a novel method for non-invasive monitoring of the fetal heart rate. PUBLIC HEALTH RELEVANCE: The current method of non-invasive monitoring of uterine activity fails frequently, particularly in the obese patient. When this occurs, often clinicians must use an invasive intra- uterine pressure catheter that is particularly problematic in these patients since they are already at increased risk for infections. The development of an alternative, inexpensive sensor replacement technology that allows for existing monitors to non-invasively monitor uterine activity will improve diagnostic data, reduce required nursing interventions, and reduce infectious complications by limiting the need for invasive monitoring.

描述（由申请人提供）：在美国，大多数产科分娩都要进行连续的电子子宫活动监测。通常，采用外部分娩力计（应变计）来提供子宫收缩的频率和时间。在某些患者中，特别是肥胖患者，监测仪无法持续检测到宫缩。在其他情况下，监护仪需要护理人员频繁重新定位。唯一可用的替代方法是侵入性宫内压力导管（IUPC），其相关的感染风险增加。产科套房是受肥胖流行病在美国，这些妇女有劳动问题，感染和其他并发症的风险增加。拟议研究的具体目标是开发一种可靠的、非侵入性的子宫活动监测仪，该监测仪不受肥胖的影响，并且比分娩力计需要更少的护理干预。最终产品将是一种名为eToco的“智能EHG电缆”，它将子宫的电活动（子宫电图或EHG）转换为与现有监护仪兼容的子宫活动信号。eToco系统将插入现有监护仪的toco或IUP端口，并提供更强大和可靠的收缩曲线，需要更少的护理干预，并提高患者的舒适度。第一阶段的结果表明，EHG可以提供这样一个简单的四电极阵列的监测。电极阵列将是一个带有粘性背衬的单个网格，便于放置。本项目提出了以下具体目标：目标1：构建生产等效原型，以共同替换EHG硬件、软件和电极网-将根据第一阶段中发现的最佳定位设计电极网/阵列并制作原型。此外，还将设计和制造eToco系统的生产等效硬件和嵌入式软件。为了支持FDA批准，将在产品设计期间启动质量体系。目标二：对网状EHG子宫活动监测仪进行临床评价-所有数据将按照FDA药物临床试验质量管理规范（GCP）的标准收集，并足以提供统计学显著性。临床研究分为两部分：第一部分将在130名患者中评价该系统与toco和IUP的对比，第二部分将评价熟练临床医生对三种信号的解释，以确保相似性。目标3：准备提交生育替代系统的FDA 510（k）-本项目期间将实施所有必要的质量控制系统。此外，还将准备510（k）申报资料。目标4：用于胎儿心率监测的声学传感器的初步测试-下一代产品将包括更可靠的超声FHR传感器替代品。一个原型的声学传感器将被测试作为一种新的方法，胎儿心率的非侵入性监测。 公共卫生相关性：目前无创监测子宫活动的方法经常失败，特别是在肥胖患者中。当这种情况发生时，临床医生通常必须使用侵入性子宫内压力导管，这在这些患者中尤其成问题，因为他们已经处于感染的增加的风险中。开发一种替代的、廉价的传感器替代技术，允许现有的监测器非侵入性地监测子宫活动，将改善诊断数据，减少所需的护理干预，并通过限制对侵入性监测的需求来减少感染并发症。